ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day
- Product NDC
- 0280-8273
- 11-digit product format
- 002808273
- Labeler code
- 0280
- Product ID
- 0280-8273_53371691-250f-5039-e063-6394a90a6ea9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 500; 20; 400; 10 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| GUAIFENESIN | 400 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1550968 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 53371691-2510-5039-e063-6394a90a6ea9 | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ALKA SELTZER PLUS Cold Day and Night Effervescent | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Sincronia Logistica, S.A. de C.V. | c478df69-823a-4112-8f44-323249a9f38f | 2023-10-23 | Warnings | M012 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | P & L Development, LLC | 169006cb-7dc2-4113-a289-0b1f14e784b7 | 2023-10-23 | Warnings | M012 |
| Night-Time Cold and Flu Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | HealthLife of USA | 2ffd62a6-703f-4cb0-bb13-49719c004d00 | 2023-10-21 | Warnings | M012 |
| Day-Time Cold and Flu Relief | ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN | HealthLife of USA | c5f6cf22-2aaa-40e1-b7b3-448e55898d62 | 2023-10-21 | Warnings | M012 |
| PENTREXCILINA | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Healthlife of USA | ae9ada14-0ec8-4c01-a874-237f2108936a | 2023-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | APNAR PHARMA LP | e5004c10-3877-c199-e053-2a95a90aa8ac | 2023-10-21 | Boxed warning, Warnings | M012 |
| Day and Night Multi Symptom Cold and Flu Relief | DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF | Intrivo Diagnostics Inc. | a311bf39-de6c-4ed5-949e-718ad8be1e49 | 2023-10-13 | Warnings | M012 |
| Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 2023-10-10 | Warnings | M012 |
| Triacting Daytime Cold Cough Childrens | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8656aa2e-9546-4de4-9ecc-ce99bf903333 | 2023-10-10 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL | Walgreens | a33ae35b-1cde-4a3d-a836-3b169e4f1bb9 | 2023-10-10 | Warnings | M012 |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 553d01a9-e8ad-4797-b55b-32f134f08af9 | 2023-10-10 | Warnings | M012 |
| Mucus Relief Maximum StrengthCold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 8781e2c5-ad46-4615-a0d9-879590e86f95 | 2023-10-10 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 419df833-1f33-45cf-bab3-730c928d5887 | 2023-10-10 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 93a5cb36-3262-4224-a5be-5ea1619a67bd | 2023-10-10 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN | CVS Pharmacy | 782fb103-cd9f-4e8c-8f3a-1fb131b9eda6 | 2023-10-09 | Warnings | M012 |
| Cold and Congestion Childrens Nighttime | DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL | Walgreens | a7847413-e556-4f88-8a7f-a8528afbe927 | 2023-10-09 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | 06d2c6cf-0adb-91b9-e063-6294a90aff52 | 2023-10-03 | Warnings | M012 |
| NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Lil' Drug Store Products, Inc. | e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b | 2023-10-02 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | PD-Rx Pharmaceuticals, Inc. | ac8c0c15-b305-47f2-8712-e4b53636f7fa | 2023-10-02 | Warnings | M012 |
| Maximum strength Day cold and flu and Night severe cold and flu | ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS | TIME CAP LABORATORIES,INC | fff69901-965c-5372-e053-6394a90a29c2 | 2023-09-18 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0280-8273-06 | 00280827306 | 6 PACKET in 1 CARTON (0280-8273-06) / 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2026-06-01 | No | No | Current |